GVV858 alone or with fulvestrant or letrozole for HR+/HER2- breast cancer and other advanced tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase I/II trial gives GVV858 as a single agent and in combination with fulvestrant or letrozole across several advanced cancer cohorts. Phase I uses dose-escalation with possible expansion cohorts to define safety, tolerability, and a recommended dose for further study. A combination arm may proceed into a randomized, open-label Phase II with optional dose optimization specifically in HR+/HER2- advanced breast cancer. Efficacy signals will be explored alongside safety, with expansion cohorts stratified by disease type and CCNE1 amplification where applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years old.
* Patients with one of the following histologically or cytologically confirmed advanced cancers:
* Phase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator):

  * HR+/HER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4/6i and at least one additional line of systemic therapy for metastatic disease.
  * Locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.
  * Metastatic castration-resistant prostate adenocarcinoma (mCRPC), with no documented neuroendocrine component, castrate level of testosterone. For dose expansion only: no more than 3 prior lines of systemic therapy for metastatic disease.
* Phase II:

  • HR+/HER2- aBC with disease progression on or after an endocrine therapy in combination, with a CDK4/6 inhibitor for advanced disease with no more than 2 lines of endocrine therapy and no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease.
* Measurable disease as determined by RECIST v1.1.

  * BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.
  * mCRPC only: If no measurable disease is present per PCWG3 modified RECIST, then at least 1 metastatic lesion must be present on bone scan imaging.

Exclusion Criteria:

* Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
* Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including myocardial infarction (MI), coronary artery bypass graft (CABG), long QT syndrome, or risk factors for Torsades de Pointes (TdP).
* Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.
* Patients with visceral crisis.
* For patients with BC: Patient is concurrently using hormone replacement therapy.
* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Tennessee Oncology PLLC
  Nashville, Tennessee, United States Recruiting
• Start
  San Antonio, Texas, United States Recruiting
• Novartis Investigative Site
  Toronto, Ontario, Canada Recruiting
• Novartis Investigative Site
  Olomouc, Czechia Recruiting
• Novartis Investigative Site
  Odense C, Denmark Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.